510(k) K930235 ยท GGP Test, Qualitative And Quantitative Factor Deficiency
HEMOCHRON/FACTOR VI WHOLE BLOOD FACTOR VIII ASSAY
| Applicant | Technidyne Corp., Edison NJ, US |
| Decision | Substantially Equivalent, Sep 2, 1993 |
| Received | Jan 5, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K930235
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.